Trifarotene safe, efficacious in facial, truncal acne

In three phase 3 clinical trials, trifarotene 50 µg/g cream demonstrated efficacy and safety in the treatment of both facial and truncal acne, according to a poster presented at the American Academy of Dermatology virtual meeting.

Two identical double-blind, randomized 12-week trials evaluated the safety and efficacy of trifarotene 50 µg/g, which was recently approved by the FDA for the treatment of acne vulgaris in patients 9 years of age and older, in 2,420 subjects.

Success in both trials was defined as a two-grade or more improvement from baseline in Investigator Global Assessment (IGA) score, a two-grade or more improvement in Physician Global Assessment (PGA) score and an absolute change in facial and truncal inflammatory lesion count.

Subjects in the treatment arm of the first trial had a mean facial IGA improvement of 29.7% at 12 months compared with 20% in the vehicle arm. The mean trunk PGA improvement was 35.8% for those in the trifarotene group and 25.7% in the vehicle group.

The second study saw greater results, with a mean facial IGA improvement of 42.8% and a mean truncal PGA improvement of 43.1% compared with mean improvements in the vehicle arm of 25.8% and 30.1%, respectively.

In a separate 52-week single-arm study evaluating the long-term safety and tolerability of trifarotene, 57 subjects (12.6%) had treatment-emergent adverse events including pruritus, irritation and sunburn.

“Mean tolerability scores peaked early in treatment and remained below mild on both face and trunk,” the authors wrote.